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Efficacy and Safety of Jaktinib in Participants With Severe Novel Coronavirus Pneumonia(COVID-19) (COVID-19)

Primary Purpose

COVID-19, Pneumonia

Status
Not yet recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Jaktinib hydrochloride tablets
Jaktinib hydrochloride tablets
Placebo
Sponsored by
Suzhou Zelgen Biopharmaceuticals Co.,Ltd
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for COVID-19

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 18 years of age, male or female; The Participants was diagnosed with novel coronavirus pneumonia; It meets the heavy-duty standards of the new coronavirus pneumonia diagnosis and treatment protocol (version 9). Participants who voluntarily sign informed consent. The National Institute of Allergy and Infectious Diseases Sequential Scale (NIAID-0S) score is 5 or 6; Exclusion Criteria: Participants who cannot take orally, or are suspected to be allergic to Jaktinib, similar drugs or their excipients, or have severe gastrointestinal dysfunction that affects drug absorption; Participants who have received the following treatments within the specified time window before randomization: Participants have received Janus kinase (JAK) inhibitor, interleukin 6 (IL-6) inhibitor, IL-1 inhibitor, tumor necrosis factor (TNF) inhibitor, T cell or B cell depletion agent, interferon and other immunosuppressive drugs within the first two weeks of randomization, except glucocorticoid; Systematically used CYP 3A4 potent inhibitor or potent inducer in the first five drug half lives at random; Immune deficiency;

Sites / Locations

  • The Third People Hospital of Shenzhen

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

Jaktinib 75mg BID

Jaktinib 100mg BID

Placebo

Arm Description

Jaktinib 75mg BID

Jaktinib 100mg BID

Placebo

Outcomes

Primary Outcome Measures

The proportion of Participants who develop death or respiratory failure.
Respiratory failure is defined as Participants who on invasive mechanical ventilation or Extracorporeal Membrane Oxygenation(ECMO) or on non-invasive ventilation or high-flow oxygen devices.

Secondary Outcome Measures

The proportion of Participants who develop death or respiratory failure.
Respiratory failure is defined as Participants who on invasive mechanical ventilation or ECMO or on non-invasive ventilation or high-flow oxygen devices.

Full Information

First Posted
January 18, 2023
Last Updated
October 20, 2023
Sponsor
Suzhou Zelgen Biopharmaceuticals Co.,Ltd
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1. Study Identification

Unique Protocol Identification Number
NCT05702788
Brief Title
Efficacy and Safety of Jaktinib in Participants With Severe Novel Coronavirus Pneumonia(COVID-19)
Acronym
COVID-19
Official Title
A Multicenter, Randomized, Double-blind, Placebo-parallel Controlled Study to Evaluate the Efficacy and Safety of Jaktinib Hydrochloride Tablets in Participants Receiving the Best Available Treatment for Severe Novel Coronavirus Pneumonia
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
December 2023 (Anticipated)
Primary Completion Date
January 2024 (Anticipated)
Study Completion Date
June 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Suzhou Zelgen Biopharmaceuticals Co.,Ltd

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This study adopts a randomized, double-blind, placebo parallel control design, and is expected to include 168 eligible patients with severe novel coronavirus pneumonia.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19, Pneumonia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
168 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Jaktinib 75mg BID
Arm Type
Experimental
Arm Description
Jaktinib 75mg BID
Arm Title
Jaktinib 100mg BID
Arm Type
Experimental
Arm Description
Jaktinib 100mg BID
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo
Intervention Type
Drug
Intervention Name(s)
Jaktinib hydrochloride tablets
Intervention Description
75mg of Jaktinib administered orally Twice daily(BID) with best available treatment.
Intervention Type
Drug
Intervention Name(s)
Jaktinib hydrochloride tablets
Intervention Description
100mg of Jaktinib administered orally Twice daily(BID) with best available treatment.
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Placebo (given as two placebo tablets) administered orally BID with best available treatment.
Primary Outcome Measure Information:
Title
The proportion of Participants who develop death or respiratory failure.
Description
Respiratory failure is defined as Participants who on invasive mechanical ventilation or Extracorporeal Membrane Oxygenation(ECMO) or on non-invasive ventilation or high-flow oxygen devices.
Time Frame
28 days after randomization
Secondary Outcome Measure Information:
Title
The proportion of Participants who develop death or respiratory failure.
Description
Respiratory failure is defined as Participants who on invasive mechanical ventilation or ECMO or on non-invasive ventilation or high-flow oxygen devices.
Time Frame
14 days after randomization

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 18 years of age, male or female; The Participants was diagnosed with novel coronavirus pneumonia; It meets the heavy-duty standards of the new coronavirus pneumonia diagnosis and treatment protocol (version 9). Participants who voluntarily sign informed consent. The National Institute of Allergy and Infectious Diseases Sequential Scale (NIAID-0S) score is 5 or 6; Exclusion Criteria: Participants who cannot take orally, or are suspected to be allergic to Jaktinib, similar drugs or their excipients, or have severe gastrointestinal dysfunction that affects drug absorption; Participants who have received the following treatments within the specified time window before randomization: Participants have received Janus kinase (JAK) inhibitor, interleukin 6 (IL-6) inhibitor, IL-1 inhibitor, tumor necrosis factor (TNF) inhibitor, T cell or B cell depletion agent, interferon and other immunosuppressive drugs within the first two weeks of randomization, except glucocorticoid; Systematically used CYP 3A4 potent inhibitor or potent inducer in the first five drug half lives at random; Immune deficiency;
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zhentian Zhao
Phone
+86-021-58382983
Email
zhaozt@zelgen.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hongzhou Lu
Organizational Affiliation
The Third People Hospital of Shenzhen
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Third People Hospital of Shenzhen
City
Shenzhen
State/Province
Guangdong
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hongzhou Lu
Phone
075561238920
Email
luhongzhou@fudan.edu.cn

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Efficacy and Safety of Jaktinib in Participants With Severe Novel Coronavirus Pneumonia(COVID-19)

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